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Quantra Testing: Help us stay compliant

27 Jul 2025

Review guidelines, intended use statements



By: Stacy Palmer, Point of Care Technical Specialist and Supervisor

As we mark two years of viscoelastic testing with the Quantra Hemostasis Analyzer at Salem Health, we want to thank you for your continued support and remind all providers of the importance of maintaining strict regulatory compliance.

The Quantra system is FDA-approved for specific patient populations only. Use outside of these approved indications is considered off-label, is not permitted under Salem Health policy, and poses serious risks, including:

  • Regulatory citations
  • Loss of testing privileges
  • Potential jeopardy to our facility’s accreditation 

Approved patient populations:
  • Patients 18 and older.
 
QPlus Cartridge:
  • Cardiovascular and major orthopedic surgery patients
 
QStat Cartridge:
  • Trauma and liver transplant patients
 
Testing outside of these populations:
  • Is not approved
  • Is not compliant with our internal policies
  • May result in regulatory violations and organizational risk
 
To support your understanding, here are the intended use statements directly from the FDA 510(k) Decision Summaries:
 
QPlus Cartridge:
  • “The Quantra QPlus System is indicated for the evaluation of blood coagulation in perioperative patients age 18 years and older to assess possible hypocoagulable and hypercoagulable conditions in cardiovascular or major orthopedic surgeries before, during, and following the procedure.”
 
QStat Cartridge:
  • “The QStat Cartridge is indicated for the evaluation of blood coagulation and clot lysis in patients age 18 years and older to assess possible hypocoagulable and hypercoagulable conditions in trauma and liver transplantation procedures. Results obtained with the QStat Cartridge should not be the sole basis for patient diagnosis.”

We are pleased to offer this critical and impactful testing for our patients. Please help us continue to maintain compliance so we may continue to offer this testing and the best care to our patients.

Questions? Contact Stacy Palmer, Point of Care Technical Specialist and Supervisor, at 503-814-3696.